Regeneron Pharmaceuticals said on Friday it halted its antibody drug clinical study to treat some of the weakest COVID-19 patients because of potential safety concerns.
Recommendation from an independent surveillance panel marked the second time that the clinical trial of an experimental coronavirus antibody drug was halted because of safety concerns.
Regeneron says it is halting admission of hospitalized COVID-19 patients receiving mechanical ventilation or intense oxygenation after the independent monitoring committee found “a potential safety signal and a risk profile. / unfavorable benefits at this time ”.
The Board of Supervisors suggested collecting additional data on registered patients.
The suspension does not affect other Regeneron antibody studies being considered to grant emergency use to mild to moderate outpatient with high risk with poor results.
Earlier this week, the company said a separate study had certainly shown a significant decrease in the amount of virus and the need to see more doctor.
The Data Monitor also recommends continued trial registration of hospitalized patients who need little or no oxygen.
Earlier this month, another watchdog recommended suspending enrollment in a research trial of an antibody drug Eli Lilly to investigate possible safety issues in hospitalized patients.
In MondayThe National Institute of Allergy and Infectious Diseases (NIAID), which funded the study, announced that there is no longer a safety issue, but research was stopped as the board saw little clinical benefit. in treatment.
Monoclonal antibodies are a laboratory-generated version of one of the body̵7;s main defense systems against pathogens.
There are no approved antibody drugs yet, but they have recently gained attention President TrumpDonald John TrumpBiden’s campaign took down Facebook after thousands of ads were blocked by the Mnuchin platform’s pre-election outage incident saying he was aware of Pelosi’s letter to him about the calls. Harris will head to Texas on ‘stimulus’ talks on Friday after polls reveal a binding relationship between Trump, Biden MORE said he received the Regeneron’s antibody cocktail and touted it as a “miracle” and a “cure”.
While the treatments are improving, there is no cure and the available treatments depend on how sick a person is.
Director of NIAID Anthony FauciAnthony Fauci Listening to the experts is not perfect, but ignoring them is much worse. Fauci: Maybe 2022 before the United States sees ‘some differences in normality’ Fauci expressed his support for ADDITIONAL national mask duty This week said treatment is all about timing; dexamethasone and other steroids can help patients with severe ventilatory problems, as well as the antiviral drug remdesivir. On the other hand, studies with experimental antibody treatments show that they are most effective when used outpatiently for people with mild symptoms.